Filed under: Safety

The FDA is taking steps to protect and educate consumers about sun exposure and sunscreen products. Choose "broad spectrum" products for greatest protection.

Warfighters are deployed to all kinds of environments, including hot and dry conditions where sun exposure is a concern. Choosing a "broad-spectrum" product that protects against sunburn, skin cancer, and premature skin aging is important, but product labeling can be confusing. Now, however, the Food and Drug Administration (FDA) is taking steps to regulate the labeling of sunscreen products in order to help consumers choose a product that will protect them from sun damage to the skin.

The new measures include a regulation, effective one year from now, that requires sunscreens to undergo a standard test if they want to be labeled as a “broad spectrum” product. Those that pass the test will be allowed to use “broad spectrum” on their packaging, which indicates a product that provides protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA). UVB rays are primarily responsible for sunburn, but both UVA and UVB rays are harmful and can cause sunburn, skin cancer, and premature skin aging.

Other provisions in the FDA regulation include:

A warning about the risk of skin cancer and early skin aging on the labels of sunscreen products that are not broad spectrum.

The amount of time the consumer can expect protection from a product with water resistance claims must be stated on the front label. The FDA, based on standard testing, will allow either a 40-minute or 80-minute timeframe on labels.

Products will no longer be allowed make a claim of “waterproof” or “sweatproof” or use the term “sunblock,” nor can they make the claim of immediate or instant protection or protection for more than two hours without reapplication.

This relatively recent supplement targeting the exercise performance market has been growing in popularity, but the limited information about its “recipe” and the severe warnings on its label and website should make potential users think twice.

Jack3d (sometimes known as “Jacked”) is, according to the bottle, a “powerful pre-workout supplement that increases your capacity to perform.” HPRC did an extensive search for evidence-based information on Jack3d and found that all the apparently scientific literature on the product led to its promotional website, where they offer their own reviews. Anyone taking supplements should know that there have been reports about “tainted” dietary supplements containing active ingredients of FDA-approved drugs or other compounds that are not classified as dietary supplements. But there are still testimonials, blog entries, and bodybuilding forums touting the effects of Jack3d. It’s important to know exactly what is in Jack3d and that there isn’t any information on how much of each individual ingredient is in a serving.

The label of Jack3d says that it contains 4145 mg of a “Proprietary Blend” in one scoop, with 45 servings per container. In that blend are the ingredients:

arginine alpha-ketoglutarate,

creatine monohydrate,

beta alanine,

caffeine,

1,3-dimethylamylamine (geranium [stem]), and

schizandrol A,

as well as some flavoring and color additives.

So, what does this all mean to a consumer? There have been individual studies conducted on each of the ingredients in Jack3d. Some are more effective than others for potentially enhancing athletic performance and building muscle mass. For example, creatine may increase muscle mass and enhance exercise performance during short, high-intensity repeated exercise bouts. For more information about creatine, see HPRC’s research brief. We know that 1,3-dimethylamylamine (DMAA), a chemical from the geranium plant and also synthetically made, is used in supplements promoted for weight loss, bodybuilding, and enhanced athletic performance. According to the Natural Medicines Comprehensive Database, it’s thought to have stimulant effects. Its chemical structure is similar to that of amphetamine, and it is on the World Anti-Doping Agency’s banned substance list. No scientific literature exists on the effectiveness of DMAA for weight loss, bodybuilding, or enhanced athletic performance. Caution is advised on the use of DMAA with caffeine, since both have stimulant effects and could increase the chance of increased heart rate and blood pressure.

The amount of caffeine per scoop of Jack3d has not been released, although it has been estimated that there is less than 150 mg of caffeine/scoop. Caffeine is included on the FDA’s list as a substance “generally recognized as safe.” However, the FDA has established a maximum concentration for caffeine in cola beverages: 32.4 mg per 6 oz or 71 mg per 12 oz. Other than colas, the caffeine content of food and beverages is not regulated. The label of Jack3d states: “Do not use in combination with caffeine or any stimulants from other sources whatsoever, including but not limited to, coffee, tea, soda and other dietary supplements or medications.” Caffeine seems to increase physical endurance, but it does not seem to affect activities that require high exertion over a short period of time, such as lifting.

The main issue with Jack3d is the same one that exists with many bodybuilding products on the market. There is no way to judge the interaction between the ingredients, especially when the consumer is unable to determinehow much of each ingredient is in the product. This product contains multiple ingredients and, potentially, additional and potent ingredients not listed. It also could be contaminated, as has been seen with many other supplements. The FDA has put together information on tainted products promoted for bodybuilding.

It is important to mention that Jack3d comes with serious warnings on its label. As with any supplement, be educated, be advised, and consider all the unknowns before you decide whether the possible benefits are worth risking your health.

The FDA seizes probiotic products from Minnesota company that makes unproven disease claims.

Probiotic products were seized by U.S. Marshals after the Food and Drug Administration (FDA) complained that the products were marketed as drugs. The company who sells the probiotic products claims that the products will prevent or treat disease, which is in violation of the Federal Food, Drug, and Cosmetic Act. More information is provided in the FDA News Release.

Visit the website of the National Center for Complementary and Alternative Medicine for information on many of the herbs used as and in dietary supplements.

The National Center for Complementary and Alternative Medicine (NCCAM) has produced a series of fact sheets on specific herbs and botanicals. Find information on common names, uses, potential side effects, and other information by choosing any of the 45 herbs or botanical fact sheets.

The USDA recommendations for cooking various types of meet offer important and useful guidelines, including some changes from previous directions.

The United States Department of Agriculture’s (USDA) new cooking guidelines for meats include a reduced “safe” cooking temperature for whole cuts of pork to 145ºF (down from 160ºF). They recommend using a food thermometer and allowing a three-minute rest time before serving. For whole cuts of beef, veal, and lamb, the safe temperature is the same—145ºF—but the new guidelines add a three-minute rest time after these meats, too, are removed from a heat source. For additional information, including the recommendations for cooking ground meats and poultry, read the new cooking guidelines.

The FDA is warning consumers not to buy or use products claiming to antimicrobial and marketed as dietary supplements.

The Food and Drug Administration (FDA) is warning consumers to stop using dietary supplement products that claim to be antimicrobial (antibiotic, antifungal, or antiviral) drugs. These products are falsely promoted to treat upper respiratory infections, sinusitis, pneumonia, bronchitis, and colds, and they look like antimicrobial products sold in Mexico. More information, including product names, is provided in the FDA Press Release.

The FDA is warning consumers about a counterfeit product marketed as the dietary supplement product “ExtenZe”

The Food and Drug Administration (FDA) has issued a press release to consumers warning them about a counterfeit product being represented as the dietary supplement "ExtenZe.” The counterfeit product has hidden ingredients, including tadalafil or a combination of tadalafil and sildenafil, which are active ingredients of FDA-approved drugs, making these products unapproved drugs. Taking these products with prescription medications containing nitrates could lower blood pressure to dangerous levels. More information, including the lot numbers on the counterfeit packages, is provided in the FDA Press Release.

Dietary supplements do not require approval by the FDA, so how can you know if the supplement you are considering is tainted? Read on for warning signs and new actions by the FDA that can help.

Tainted dietary supplements most often occur among products typically marketed for weight loss, sexual enhancement, and bodybuilding. They can have deceptive labeling as well as undeclared, harmful ingredients. The question is: How can consumers protect themselves from these products?

The Food and Drug Administration (FDA) has recently taken some steps to help consumers look out for potentially harmful dietary supplement products. Consumers and healthcare professionals can receive notifications from the FDA by subscribing to the RSS feed. The Commissioner of Food and Drugs also sent a letter to the dietary supplement industry reminding them of their responsibility to prevent the sale of tainted products in the United States. The FDA has also made it easier to report to the FDA about tainted products.

Some of these tainted dietary supplement products contain active ingredients of FDA-approved drugs or other compounds that are not classified as dietary ingredients. These products can have serious side effects, including death. The FDA has identified roughly 300 tainted products that are not legal dietary supplements and are warning consumers about the serious side effects of these products. Consumers should be cautious of:

Product ads that claim to “melt your fat away,” or claim that “diet and exercise [are] not required,” or products that use the words “guaranteed,” “scientific breakthrough,” or “totally safe.”

Products that use numerous testimonials about “results seen” from using the product.

Any product that is labeled or marketed in a foreign language. Consumers should not buy or consume these products.

Products that are marketed as herbal alternatives to FDA-approved drugs.

Products marketed and sold on the Internet.

There have been some recent voluntary recalls due to FDA investigations of dietary supplement products. Some of these have included weight-loss products that contained the prescription drug ingredient sibutramine. Sexual enhancement products have also been recalled for containing the undeclared drug ingredients sulfosildenafil and tadalafil. Other products marketed as supplements have been identified as containing various prescription drug ingredients.

It is important that consumers be aware that, under the Dietary Supplement Health and Education Act of 1994, companies do not need FDA approval prior to marketing such products. Thus, generally speaking, the FDA does not approve dietary supplements.

Consumers need to be savvy when they make product purchases, and when in doubt, check with a healthcare professional or registered dietitian to determine if you need a dietary supplement product and to help determine what could be a tainted product. If it looks too good to be true, chances are it is. For more information, read the “FDA’s Beware of Fraudulent ‘Dietary Supplements’.”

2010

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